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Omron Heart Guide Wrist Blood Pressure Monitor, Large
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Omron Heart Guide Wrist Blood Pressure Monitor, Large FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Wearable Wrist Blood Pressure Monitor with Fitness and Sleep Tracking FDA UDI
- Model / Reference
- BP8000-L FDA UDI
- Description
- Wearable Wrist Blood Pressure Monitor with Fitness and Sleep Tracking FDA UDI
Identifiers
- Catalog Number
- BP8000-L FDA UDI
- Primary DI / UDI-DI
- 00073796268022 FDA UDI
- 510(k) Number
- K190693 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Omron Heart Guide Wrist Blood Pressure Monitor, Large by Omron Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automatic-inflation electronic sphygmomanometer, portable, arm/wrist.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Omron Healthcare, Inc.
Sources (1)
- FDA UDI 4b0a84c8-6e93-4c7a-b554-e1948ad8d934 37 fields · synced May 31, 2026